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CPJE 2024 EXAM/289 QUESTIONS AND ANSWERS/100% CORRECT
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CPJE 2024 EXAM/289 QUESTIONSAND ANSWERS/100% CORRECT
Poison Prevention Packaging Act- place ORAL (only) Rx meds in child-
resistant safety containers. What are the exceptions? - -- Nitroglycerin SL
tab
- Erythromycin ethylsuccinate granules for oral suspension
- colestipol powder (Colestid- BAS)
- oral contraceptives in manufacturer's memory-aid dispenser packages
- Doctor or patient may request a non-complying container (keep
documentation if that occurs)
-erythromycin oral counseling - -Base, PCE or stearate dosage forms should
be taken on an empty stomach
Ethylsuccinate (E.E.S. Granules) or delayed-release (Ery-Tab) admin without
regard to meals--> May consider administering after food to decrease GI
discomfort.
-DEA Form 222 - -Ordering of Schedule I & II C.S requires DEA Form 222
- keep record for 3 YEARs
- Pharmacies can sell to other pharmacies or to prescribers with DEA 222
form (C I & II) --> can sell MAX 5% of their C.S dispensing
(ie. can sell 1,000 to another pharmacy if dispense 20,000 C.Subs)
- Valid for up to 60 days
- The reverse distributor issues DEA Form 222 for C.S. II.
-Transfer of Schedule II C.S - -Schedule II C.S canNOT be transferred (DEA
Form 222 is NOT used to transfer prescriptions)
-Filing of prescriptions - -Schedule III, IV, or V C.S prescriptions REQUIRE a
1-inch red 'C' on lower right corner if filed along with NON-scheduled
prescriptions
- does not apply for electronic filing systems
- EXCEPTION: Schedule II C.S prescriptions MUST be filed separately
-Paper or electronic C.S prescription records must be kept for: - -- Federal: 2
years
- CA: 3 years
- When there's a conflict between a federal and a state statute, the federal
statute outweighs the state statute or regulation, unless the state law is
more stringent and, thus, mandates over the less stringent federal rule.
, -Refill PRN (non-scheduled drugs) - -valid for 1 year from the date
prescription was written
-CA Continuing Education Requirements - -- 30 hours CE/2 years
- 2 of the 30 CE hours MUST be law & ethics from a course provided by the
Board
- retain CE certificates for 4 years
-REMS (Risk Evaluation and Mitigation Strategies) - -- required by the FDA
for some drugs
- developed by manufacturer and approved by FDA to ensure benefits
outweigh risks, ensure appropriate prescribing and minimize patient risk
-Recalls, Market Withdrawals, & Safety Alerts - -Recall: remove a product
from market by a firm's own initiative, FDA request/order
- Class I recall: reasonable probability of serious adverse health
consequences/death
- Class II: may cause temporary/reversible S.E; probability of serious
consequence is remote
- Class III: not likely to cause adverse health consequences
- Market withdrawal: firm removes the product from market and/or corrects
minor violation
- Medical device safety alert: unreasonable risk of substantial harm (in some
cases, these situations also considered recall)
-Board must be notified within... - -- 30 days: change of ownership, address
or name/PIC/pharmacy permit, theft/diversion/drug loss
- 14 days: licensed employee is found chemically/mentally/physically
impaired
- Controlled substances: losses must be reported to the Board no later than
30 days (notify DEA immediately) --> if the cause is theft, diversion or self-
use, loss must be reported within 14 days
- Immediately: bankruptcy/insolvency/receivership
-Transfer of drugs notice - -upon closure of a pharmacy, notice must be
provided to the Board within 10 days (in writing)
- 'Closed-Down' pharmacy= pharmacy no longer engaged in ordinary activity
for at least 1 day/week during any 120 day period
- Board may issue a temporary permit for 180 days during a transfer of
ownership in order for that pharmacy to continue its operations
-Time Limit Requirements in Keeping of Pharmacy Records: 1-year - -- pt
medication profile
,- pt medication error
- quality assurance programs
- patients consent to enroll in automatic refill program
-Time Limit Requirements in Keeping of Pharmacy Records: 2-years - --
ephedrine, pseudoephedrine & phenylpropanolamine sale logs
-Time Limit Requirements in Keeping of Pharmacy Records: 3-years - --
Community/clinic pharmacy prescriptions
- U.S Official Order Forms (DEA Form 222)
- C.S inventories
- theft and losses reports (DEA Form 106)
- Pharmacy self-assessments
- return of drugs to wholesaler or manufacturer
- laminar air flow hoods certification
- transfer or sales to other pharmacies and MDs
- purchase invoices
- hospital pharmacy chart order records for non-controlled drugs
-Time Limit Requirements in Keeping of Pharmacy Records: 4-years - -C.E
certificates
-Time Limit Requirements in Keeping of Pharmacy Records: 6-years - -HIPAA
Notice Records signed by the patients
-Time Limit Requirements in Keeping of Pharmacy Records: 7-years - -
Hospital pharmacy chart order records for CONTROLLED substances
-Off-site Storage waiver - -- records for non-controlled subs must be kept in
the pharmacy for at least 1 year & minimum 2 years if CS
- a pharmacy that wishes to store prescription records off-site after these
time limits, must have a WAIVER APPROVAL from the Board and records
must be retrievable within 48 hours (2 business days)
-Automatic Refill Program - -- pt may enroll by written, online, or electronic
informed consent to participate for ea/new Rx wherein there is a change in
med, strength, dosage form or directions for use
- keep patient's consent to enroll for 1 year
- annual renewal + drug regimen review at the time of refill + notification
(for ea/refill) to the patient that Rx is being refilled via program
-Pharmacy self-assessment survey - -- pharmacies, compounding
pharmacies and wholesalers must complete self-assessments by July 1st of
each odd-numbered year
- completed assessments kept @ facility for 3 years
- submitted to the Board ONLY if requested
, - ALSO, new self-assessment forms must be completed WITHIN 30-days
whenever:
a) new license is issued
b) change in PIC or designated representative-in-charge
c) change in facility address
-Pharmacist-In-Charge (PIC) - -- operates 2 pharmacies MAX (must be within
50 miles of one another)
- responds to the pharmacy self-assessment surveys
- canNOT serve concurrently as PIC and 'exemptee-in-charge' or
'representative-in-charge' for a wholesaler or veterinary food-animal drug
retailer
- Interim PICs can only be designated for MAX 120 days
-A single pharmacist may have the following ancillary personnel working at
any time - -- 2 pharmacy interns
- Retail: 1 pharmacy technician (2 for each additional pharmacist) --> if there
are 3 Rphs = 5 techs
- Inpatient: 2 pharmacy technicians
- any reasonable number of clerks (typists)
- Note: Interns may perform all the functions of a pharmacist under
supervision (except for the FINAL verification)
-Pharmacy technician - -- must be registered with the CA BOP (background
checks)
- can obtain licensure after completion of a pharmacy tech certification
program approved by the BOP
- A pharmacy technician checking the work of other techs cannot be
operational in every hospital or community pharmacy program; it may only
occur in acute hospitals that have an ongoing clinical pharmacy program
where pharmacists are in the patient care areas; the overall operations are
the responsibility of the PIC
-Central Fill Pharmacy - -pharmacy that fills (with its own drug inventory)
prescriptions submitted to another pharmacy
- central filling pharmacy's address must be on the label
-Surgical Clinic vs. Multi-specialty Clinic - -- Surgical Clinics --> dispense 72-
hours supply
- Multispecialty Clinics--> no restrictions
-Prescriber's office & Emergency Room - -Prescriber may dispense a
prescription drug (including C.S) only if:
- drug regimen should start immediately (i.e ER)
- no pharmacy available (ie hospital with < 100 beds)
- records of drugs purchased (at wholesaler) and administered are kept
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